Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

Inclusion Criteria

• Histologically documented adenocarcinoma of the stomach or Gastroesophageal Junction (GEJ).
• Age >18 years;
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
• Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a radiosensitization is permitted, provided that the minimum time from completion of such treatment to study entry is at least 12 months;
• Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 14 days must have elapsed since the end of radiotherapy.
• Previous Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration. Minimum of 14 days must have elapsed between a major surgery and start of chemotherapy.
• At least one target lesion >20 mm (or >10 mm on spiral CT-scan). If indicator lesions are in a previously irradiated field, only a clear disease progression of the irradiated lesion or a new lesion in the previously irradiated field will be accepted
• Adequate baseline bone marrow, hepatic and renal function, defined as follows: Neutrophils >1.5 * 10*9/L and platelets >100 * 10*9/L; Bilirubin <1.5 * upper limit of the normal range (ULN); aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) <2.5 * ULN; Serum creatinine <1.5 * ULN;
• Patients must give written informed consent to participate in the study.
• Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to registration.

Exclusion Criteria

• Concurrent anticancer therapy
• Pregnant or lactating women
• History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer or malignancy from which the patient has been disease-free for 5 years;
• Brain metastases
• Patients with active or uncontrolled infections or with serious illnesses or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV and/or cirrhosis
• History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
• Known hypersensitivity to any of the drugs.